Medical Device Regulatory Affairs EU MDR (REMOTE)

Edison, NJ

Industry: Regulatory & Scientific Job Number: 147301


Medical Device Regulatory Affairs Consultant (REMOTE)

Project Description:                                                     

Our client is a large medical device company and is looking to build a team of people to help with the remediation efforts required to update their technical files and design dossiers for the EU.


Day to Day Responsibilities:

This consultant will be responsible for updating technical files and design dossiers to meet the ne EU MDR requirements.  The person chosen for this role will need to have an in depth knowledge of both EU MDD and EU MDR.  They will be responsible for reviewing a technical file, identifying where the gaps are in regard to moving it from EU MDD to EU MDR, and then conducting the hands on upgrades required to update the documents.  This person will need to be hands on as the execution side of the job is within scope.

Required Skills:

Regulatory Affairs


Job Type: Contract  

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